XIGDUO Approved in the European Union for Type 2 Diabetes


Prof. Nishi Prakash Jain
Type 2 diabetes is a growing global concern and a range of treatments are needed in order to appropriately manage this disease. The approval of Xigduo offers physicians another valuable treatment choice in the management of this progressive disease.
AstraZeneca and Bristol-Myers Squibb announced that Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union (EU). Xigduo combines dapagliflozin (trade name Forxiga), a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control, in a twice daily tablet. This is the first regulatory approval for a fixed dose combination of an SGLT2 inhibitor and metformin.
Forxiga was the first medicine in the SGLT2 class to gain regulatory approval, having received Marketing Authorisation in the EU for type 2 diabetes in November 2012, and is currently approved for the treatment of type 2 diabetes in 40 countries including the United States and Australia.


Indian pharma sector to grow to Rs 5 lakh cr by 2020: DoP

The Indian pharmaceutical sector is expected to grow 5-fold in the next seven years to reach Rs 5 lakh crore, as per government estimates.
The department envisages that the industry will grow from its current level of Rs 1 lakh crore to Rs 5 lakh crore by 2020, becoming globally competitive and building India as a global provider of quality medicines at reasonable prices, "Department of Pharmaceuticals (DoP) Joint Secretary A J V Prasad said.
The pharmaceutical sector has grown over 3.5-fold in the last 10 years to reach Rs 1,19,075.7 crore. In 2000-01, the size of the sector stood at Rs 33,0,11.8 crore.
The quick estimates for Gross Domestic product ( GDP) for 2010-11 is Rs 76,74,148 crore and the share of the pharma industry for 2010-11, which is based on CMIE data, is 1.55 per cent," a source said.
The data for 2011-12 is not available, the official said, adding that the industry size in 1990-91 stood at Rs 6,314.5 crore. For 2009-10, it was Rs 1,06,209 crore.
In order to encourage production of drugs by indigenous industries, the 12th Five Year Plan (2012-17) has recommended capacity building of private sector to meet WHO-GMP standards and other international manufacturing standards.
The major recommendations of Plan include "enabling the Indian pharmaceutical industry to develop competence in advanced areas of drug manufacturing like dedicated research facility in bulk drugs, improving processes of manufacturing generics and APIs" the source said.
The Indian pharmaceutical industry is the third largest in terms of volume, and 13th in terms of value. The sector is growing at 14 per cent per annum.